In the field of percutaneous catheter introduction, there are a variety of known methods and apparatuses for percutaneous catheter introduction .into an anatomical body cavity.
One known method uses a rigid metal catheter such as the RANFAC.RTM. laparoscopic cholangiocath manufactured by Ranfac Corp., Avon Industrial Park, P.O. Box 635, Avon, Mass. 02322. The metal catheter is inserted through an existing needle hole in the abdomen. This method is discussed in an article entitled "A New Technique of Laparoendoscopic Cholangiography," written by Kenneth D Hagan, M.D., et al. and published in The Journal of Laparoscopic Surgery, Volume 2, Number 2, 1992 by Mary Ann Liebert, Inc. The method does not use an introducer sheath or a cannula.
Another procedure for percutaneous catheter introduction is the insertion of a short catheter and introducer needle. The introducer needle is extended through the catheter and protrudes from the distal end of the catheter. The catheter and needle are inserted into the body cavity and the needle is removed from the proximal end of the catheter. The catheter has a coupling means at its proximal end for connecting to a hose, syringe, or other fluid supply means. An example of such a catheter having a seal which may be manually adjusted to close around an introducer needle inserted therein or to close the catheter completely is described in U.S. Pat. No. 4,243,034. The disclosed device does not include a separate introducer sheath for introducing the catheter.
Another procedure for percutaneous catheter introduction is the insertion into a blood vessel of a hollow IV catheter and introducer needle. The IV catheter is connected to a supply of fluids through a luer fitting or other detachable connection. The CRITIKON I.V. catheters manufactured by Critikon, Inc., 4110 George Road, Tampa, Fla. 33631 exemplify such IV catheters and introducer needles. This method also does not use a separate introducer sheath or a separate cannula.
There are certain known methods of percutaneous catheter introduction that include usage of an introducer sheath or cannula and a catheter inserted therein. In these methods generally, a needle is extended through a sheath. The needle and sheath are then inserted percutaneously by being driven through the skin to the desired location within the body cavity. The needle is withdrawn from the sheath and the catheter is inserted into the sheath. An example of this method and an accompanying apparatus is described in U.S. Pat. No. 4,613,329.
In these known methods that use an introducer sheath or cannula, there are certain variations. One known variation includes use of an IV catheter and a rigid metal catheter such as the RANFAC.RTM. laparoscopic cholangiocath discussed above. The IV catheter is inserted into the abdomen in a position to gain access to the cystic duct. The catheter needle is removed and the luer fitting is cut off, leaving a tube providing access to the abdominal cavity. The rigid metal catheter is then inserted into and extended through the IV catheter. The distal tip of the metal catheter is inserted into the cystic duct.
Another variation uses a metal catheter and introducer sheath and needle manufactured by Applied Vascular Devices, Inc., 26051 Merit Circle, Building 104, Laguna Hills, Calif. 92653. The metal catheter includes a rubber seal which snaps over the proximal end of the introducer sheath to prevent loss of pneumoperitoneum.
Another variation is described in an article entitled "Laparoscopic operative cholangiography: a simple, successful, cost effective method," written by Louis J. Fligelstone, et al., and published in the Annals of the Royal College of Surgeons of England (1992) vol 74, 252-253. The described method includes insertion of a needle and introducer cannula called a Vygon Dramcath.RTM. (Vygon (UK) Ltd., Bridge Road, Cirencester, Gloucestershire). The needle and introducer cannula are inserted into the abdominal cavity. The needle is removed and a rubber seal is placed over the luer lock. A catheter is then passed through the rubber seal and through the introducer cannula.
The disadvantage of the above methods and apparatuses that use introducer sheaths or cannulas is that fluids and gases may leak from the abdominal cavity through the lumen in the sheath when the sheath and needle are inserted into the abdomen and when the needle is withdrawn from the sheath while the sheath remains inserted in the abdomen. This undesirable leakage occurs when abdominal fluids and/or gases enter the tip of the lumen in the sheath, travel proximally in the lumen, and escape through the proximal end of the lumen outside of the abdominal cavity. When the needle is withdrawn from the sheath, this leakage can be exacerbated. It would be desirable to provide a means for sealing the sheath and needle to prevent such leakage. Further, it would be desirable to provide a means for using the introducer sheath for aspiration of fluids.
Another disadvantage of the above known methods and apparatuses is that the introducer sheath does not sufficiently guide a flexible catheter to the cystic duct. It would be desirable to provide an improved apparatus for guiding a flexible catheter to the cystic duct.
Another disadvantage of the above known methods that use an introducer sheath or cannula is that the depth of insertion of the sheath into the body cavity may be unintentionally increased. Also, after insertion, the angle of insertion may be unintentionally changed by inadvertent movement or jarring of the sheath. It would be desirable to adjustably anchor the sheath to prevent inadvertent increases in the depth of insertion and to prevent unintentional changes in the angle of insertion.